MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0007

Device Problem Stretched (1601)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

It was reported that the primary tubing is "bubbling" and the walls seem thin.There was no patient harm reported.

Manufacturer Narrative

Correction; (patient code).The customer¿s report that the primary tubing is "bubbling" and the walls seem thin was confirmed.The as-received set samples were visually inspected for kinks, incomplete bonding, holes/tears in the tubing or damages to the components.During inspection of the set sample it was observed that there was a bulge along the silicone segment.Further handling of the observed bulge area noted it felt softer/weaker as compared to the rest of the silicone segment.No other issues were observed with the set sample and no issues of concentricity with the silicone segment were observed.Previously investigated complaints for this failure mode determined that the bulge is caused by excess pressure within the silicone segment.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported that the primary tubing is "bubbling" and the walls seem thin.It has been confirmed through follow up, that there was no patient harm as a result of this event.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9215021
• MDR Text Key: 163318432
• Report Number: 9616066-2019-02920
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 30262E